Dangerous Drugs and Medical Devices

Dangerous drugs and devices which Casey Gerry's pharmceutical attorneys have evaluated

• Byetta is an injectable medication for Type II Diabetes. Recently it has been associated with 6 deaths from hemorrhagic and necrotizing pancreatitis.
• Ephedra contains ephedrine, which acts as a stimulant and bronchodilator. Prescribed appropriately, ephedrine can help asthmatics breathe more easily. Yet it poses significant health risks. Ephedrine has been associated with seizures, heart attacks, strokes, psychotic states, and death. Formerly a common ingredient in non-prescription dietary supplements.
• Fosamax is a medication used to treat bone loss, widely prescribed for post-menopausal women to prevent osteoporosis. Fosamax was developed and marketed by Merck the same company that sold Vioxx. Since 2000, an increasing number of reports have linked Fosamax to osteonecrosis of the jaw and other bones, a very serious condition in which the bone tissue loses its blood supply. The bone deteriorates dies and eventually collapse, leading to pain and arthritis.
• Gadolinium-based contrast agents (GBCA’s) are dyes used in MRI and MRA studies. In people with kidney damage use of GBCA’s has led to Nephrogenic Systemic Fibrosis, a serious and crippling disorder of the connective tissue.
• Hydroxycut is the name of a group of 14 non-prescription products sold as dietary supplements for weight loss. In May 2009 the FDA reported 23 instances of Hydroxycut users suffering serious health problems, including jaundice, liver damage, and one death due to liver failure. In its letter to health care providers the FDA stated that it believes Hydroxycut products present a serious public health risk. Hydrox Iovate Health Sciences USA, the US distributor, has withdrawn the following Hydroxycut products from the market:
  • Hydroxycut Regular Rapid Release Caplets
  • Hydroxycut Caffeine-Free Rapid Release Caplets
  • Hydroxycut Hardcore Liquid Caplets
  • Hydroxycut Max Liquid Caplets
  • Hydroxycut Caffeine-Free Drink Packets
  • Hydroxycut Hardcore Drink Packets (Ignition Stix)
  • Hydroxycut Max Drink Packets
  • Hydroxycut Liquid Shots
  • Hydroxycut Hardcore RTDs (Ready-to-Drink)
  • Hydroxycut Max Aqua Shed
  • Hydroxycut 24
  • Hydroxycut Carb Control
  • Hydroxycut Natural
  • Hydroxycut Regular Drink Packets
• Metaclopramide (sold as Reglan, Octamide, and Maxolon) is a drug which increases the stomach’s ability to empty digested food and move it on to the small intestine. The FDA advises that patients should not be kept on metaclopramide for more than three months. Longer periods of use increase the risk of Tardive Dyskinesia (“TD”), is serious neurological disorder characterized by involuntary body movements such lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers, as though the patient were playing an invisible piano. The uncontrollable movements are continuous, stopping only when the person sleeps. Tardive Dyskinesia may persist for months, even years after metoclopramide has been discontinued, and is usually not reversible. There is no known treatment for TD.
• Oral Sodium Phosphates, OSP’s, are oral medications used for bowel cleansing as preparation for a colonoscopy. Visicol® and OsmoPrep® are available only by a doctor’s prescription. Non-prescription OSP’s include Fleet Phospho Soda E-Z Prep Bowel Cleansing System and Fleet Phospho-Soda Oral Saline Laxative. Some patients have developed Acute Phosphate Nephropathy developing after using an Oral Sodium Phosphate product (OSP). Acute Phosphate Nephropathy is a severe injury to the kidney, in which deposits of calcium-phosphate crystals in the tubules, the tiny tubes that comprise much of the kidney. These crystals may cause irreversible and permanent damage to the kidneys. This very serious disorder has been seen to occur in patients who have no current kidney disease or malfunction, and no known risk factors that would increase the likelihood of developing a sudden-onset severe kidney disorder.
• OrthoEvra® birth control patch is a patch infused with birth control medication, which a woman can place on her skin for up to a week. During pre-approval clinical trials Ortho-McNeil Pharmaceutical, the manufacturer found evidence of a dangerous side effect: use of Ortho Evra® increased the risk of nonfatal blood clots for women who used it by three times that of women who used the pill.
• Paxil (paroxitine) is an antidepressant. Use of Paxil has been linked to suicidal thoughts and behaviors, especially with children and teenagers. Other adverse effects include hyperactive behavior and mania, seizures, excessive sweating, dizziness, and sexual dysfunction. Suicidal thoughts and actions may occur more frequent and pronounced with children.
• Phen-Fen, a combination of two appetite-suppressant drugs which caused primary pulmonary hypertension, a narrowing of the arteries of the heart and lung, and damage to the heart valves in some users.
• Yaz and Yasmin are oral contraceptives manufactured by the multinational pharmaceutical firm Schering, which have been linked to more than 50 deaths since 2004. Women who have taken Yaz and Yasmin have been found suffer increased incidences of gall stones, liver problems, heart attacks, strokes, and serious blood clots.
• Zicam Products including Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs, or Zicam Cold Remedy Swabs, Kids Size. These products contain zinc, and are applied directly to the inside the nose. In a letter to the manufacturer, Matrixx Initiatives, the FDA noted that zinc is known to cause anosmia, the loss of the sense of smell. Anosmia is sometimes reversible, sometimes permanent. Under pressure from the FDA, Matrixx has withdrawn these dangerous products from the market.
• Zyprexa, manufactured and marketed by Eli Lily, is a potent anti-psychotic drug, used in the treatment of various severe mental disorders. The New York Times reported that "Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers." Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes.

Recently identified defective medical devices

• The Guidant pacemaker/defibrillator is a device surgically implanted in the heart to regulate heart rhythm. The FDA’s warning stated, "A seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death." As many as 28,000 people have had this device implanted, and may be at risk.
• The Sulzer hip implant is a replacement for a severely arthritic hip joint. The Sulzer device was found to have interfered with bone growth, so that the device never seated adequately in the patients’ hip joint. Symptoms include: pain in the groin, buttocks, and thigh, difficulty standing from a seated position, difficulty walking, and a high degree of pain. Pain and difficulty walking may be so severe that the defective implant needs to be replaced. Recovery from a replacement operation requires bout three months.
• The TAXUS® stent, manufactured by Boston Scientific Inc, is a small, expandable sleeve of stainless steel mesh used to prop open a coronary artery and improve blood flow in an artery that has been narrowed by coronary artery disease. Follow-up studies have found many cases of thrombosis, or blood clot formation, at the site of the TAXUS® stent. Blood clots are extremely dangerous, because they can block the artery, causing heart attacks and even death. Patients who have had the TAXUS® stent implanted had higher rates of clotting and death 18 to 36 months after implantation than patients who had bare-metal stents. Patients who have not developed clots may still need to take expensive antiplatelet medication for a months or years period in order to prevent blood clots (thrombosis).